Online research in philosophy

OBJECTIVE: To investigate whether eligibility criteria that exclude the elderly, persons with psychiatric disease, and persons with substance abuse problems from participation in randomized controlled trials (RCTs) are subjective and hence a source of variability in enrolment decisions and investigator uncertainty. DESIGN: Survey questionnaire. PARTICIPANTS: Cancer investigators from the United States and Canada. INTERVENTIONS: Investigators were presented with clinical vignettes from 3 patient categories--eligible, ineligible and uncertain--for each of 5 eligibility criteria--3 subjective and 2 objective--and were asked whether they would enrol the patient in a trial and how sure they were of this decision. Demographic characteristics of the investigators were also collected. OUTCOME MEASURES: The difference in enrolment decisions between subjective and objective criteria, and the difference in the certainty associated with these decisions. RESULTS: Of 365 questionnaires sent out, 224 usable ones were returned. Compared with the objective criteria, the subjective criteria were associated with more variable enrolment decisions (p = 0.07 for the "eligible" scenario and p = 0.0001 for the "ineligible" and "uncertain" scenarios), and investigators were less sure about the decisions they made (p = 0.0001 for all scenarios). Demographic characteristics of the investigators failed to explain the observed differences. CONCLUSIONS: Subjective eligibility criteria may interfere with the conduct and interpretation of RCTs and, therefore, their use ought to be justified explicitly in the study protocol. RCT designers, funding agencies and research ethics boards have an important role in reviewing eligibility criteria for their necessity.

Procedures for the selection of subjects for participation in randomized clinical trials--usually formalized as eligibility criteria in the study protocol--have both scientific and ethical implications. In this thesis, I undertake an examination of eligibility criteria at three stages in the genesis and dissemination of medical knowledge: clinical trial protocol, interpretation by investigators, and reporting of study results.In the first chapter, ethical issues in subject selection are reviewed and the main study questions are presented. In the second chapter, the results of an examination of eligibility criteria in two sets of clinical trials, one sponsored by the NSABP, the other sponsored by POG, covering a twenty-year time span are presented. The POG trials had far fewer eligibility criteria than the NSABP studies, suggesting that large numbers of criteria may not be necessary for high quality research. In the third chapter, the impact of subjective eligibility criteria on enrollment and investigator uncertainty is explored. Subjective criteria were associated with more variable enrollment decisions and greater uncertainty. Such criteria represent a threat to the validity, conduct and interpretation of trials and, therefore, should only be included when carefully justified. The fourth chapter examines the accuracy of the reporting of eligibility criteria in sets of corresponding study protocol, methods paper, journal article, and Clinical Alert. Important information is lost at each step in the dissemination of study results. Unnecessary criteria ought to be dropped at a trial's inception; all other criteria must be reported faithfully. The fifth chapter attempts to provide a comprehensive philosophical account of just selection procedures for clinical research using the political philosophy of Michael Walzer. The sixth, and last, chapter, discusses explanatory and pragmatic approaches to clinical trial design, overlapping scientific and ethical concerns related to eligibility criteria, and questions for further study.

I shall here discuss some matters related to the so-called radical indeterminacy or inscrutability arguments due to, e.g., Willard v. O. Quine, Hilary Putnam, John Wallace and Donald Davidson.1 These are arguments that, on the face of it, demonstrate that there is radical indeterminacy in what the expressions in a theory refer to and in what the ontology of the theory is. I will use “inscrutability argument” as a general label for these arguments. My main topic – after I have dealt with some issues that in the context are mere preliminaries – will be what the consequences of inscrutability for ontology might be. (The label ‘inscrutability’ is not ideal, as it suggests that the problem raised is primarily epistemic. But it is common to use the label in the context of Quine’s arguments. And it has the advantage over the alternative suggestion “indeterminacy” that it signals that we are here dealing with a special kind of indeterminacy, not only more widespread but also in principle irremediable.).

We studied changes in eligibility criteria--the largest impediment to patient accrual--in two samples of clinical trials. Trials from the NSABP (National Surgical Adjuvant Breast and Bowel Program) and POG (Pediatric Oncology Group) were analyzed. After eliminating duplications, the criteria in each protocol were enumerated and classified according to a novel schema. NSABP trials contained significantly more criteria than POG trials, and added precision criteria (making study populations homogeneous) at a faster rate than POG studies. The difference between NSABP studies (explanatory trials) and POG studies (pragmatic trials) suggest that large numbers of eligibility criteria are not necessary for quality studies. We recommend that: (1) the inclusion/exclusion criteria distinction be abandoned; (2) eligibility criteria be explicitly justified; (3) the need for each criterion be assessed when new trials are planned; (4) criteria in phase III trials restricting patient accrual be minimized; and (5) further research be done to assess the impact of criteria on generalizability.

In contrast to attempts that have been made to measure the clarity of reporting of the methods of clinical trials in journal articles, we report here an attempt to measure the accuracy of methods reporting. We focus in this article on eligibility criteria as a test case for the reporting of clinical trial methods. We examined the reporting of eligibility criteria in the protocol, methods paper (if applicable), journal article, and Clinical Alert for articles appearing in print between January 1988 and September 1994 for which a Clinical Alert had been issued. Eligibility criteria were further classified into five categories in order to examine the content of information loss, if any. On average, 82% of protocol eligibility criteria were reported in methods papers. Journal articles and Clinical Alerts fared somewhat worse: 63% of criteria were reported in journal articles, 19% in Clinical Alerts. In all three categories of medical communication, the reporting of criteria that defined the study disease tended to be complete; reporting of criteria relating to trial precision, patient safety, legal and ethical concerns, and administrative considerations, was not complete. We found that criteria for clinical trial eligibility are frequently under-reported in medical communications. Moreover, some of the criteria omitted are of considerable clinical importance. We suggest that in the design phase of clinical trials, proposed eligibility criteria be scrutinized closely. Those criteria that survive this scrutiny and that have clinical import must be reported upon fully and accurately when communicating trial results.

Although facially clear, the natural-born citizen provision of Article II's presidential eligibility clause has never been definitively interpreted by the courts. This paper considers whether the concept of natural-born is a self-defining concept, or whether instead it is a concept that is subject to a variety of interpretive theories. It does so by examining the traditional interpretive approach adopted by Constitutional scholars for examining the intended meaning of Article II's presidential eligibility requirements. Such an analysis finds that the traditional approach is inadequate, particularly in light of neglected aspects of English common law, the lack of congruency of the English legacy with the American political experiment, the passage of the Fourteenth Amendment, and the history of congressional regulation in this area. The paper responds to these problems within existing traditions of natural born interpretation by proposing a new approach that includes a recognition of Congress's constitutional power to extend natural born citizenship to classes of citizens beyond those born within the territorial boundaries of the United States. Discussion concludes with an examination of how application of the new interpretative approach would expand the number of American citizens who may be considered natural born for purposes of presidential eligibility; how Congress might operationalize these new understandings; and why reconceptualization of the meaning of the citizenship clause is preferable to previous interpretations of Article II.

According to Eli Hirsch, non-commonsensical ontological claims just couldn’t be true. Oversimplifying: there is strong metasemantic pressure on correct interpretations of natural language to be charitable—to count a sentence as true if ordinary speakers regard it as being obviously true. Ordinary speakers regard sentences like “There is at least one building in New York City” and “Nothing is composed of Socrates’s nose and the Eiffel tower” as being obviously true; and there is no countervailing metasemantic pressure; so correct interpretations count them as true; so they are true. So non-commonsensical ontological views that say otherwise can be seen to be wrong—simply by attending to metasemantics. One source of countervailing metasemantic pressure might be Lewisian reference magnetism. David Lewis (1983, 1984) has argued on independent grounds that metasemantics cannot be based solely on charity, and that another source of metasemantic pressure is “eligibility”: good interpretations must, as much as possible, assign meanings that “carve at the joints”. So one reply to Hirsch, which I offered in my paper “Ontological Realism” and elsewhere, is that i) there are joint-carving meanings that are suitable to be meant by quantifiers; ii) Lewisian reference magnetism is true; and iii) charity is trumped by the eligibility of an interpretation that assigns the joint-carving meanings to the quantifiers.1 I also proposed a backup reply (to which I’m increasingly partial). Suppose that i) is true but either ii) or iii) is false. Suppose, that is, that although there are indeed joint-carving quantifier meanings, either Lewis is wrong that eligibility counts in metasemantics or else eligibility does count but not enough to outweigh charity in this case. Then Hirsch would be right about ontological claims in natural language; but ontology could instead be conducted in “Ontologese”, a language in which quantifiers are stipulated to stand for the joint-carving meanings..

When a belief set is contracted only some beliefs are eligible for removal. By introducing eligibility for removal as a new semantic primitive for contraction and combining it with epistemic entrenchment we get a contraction operator with a number of interesting properties. By placing some minimal constraint upon eligibility we get an explicit contraction recipe that exactly characterises the so called interpolation thesis, a thesis that states upper and lower bounds for the amount of information to be given up in contraction. As a result we drop the controversial property of recovery. By placing additional constraints on eligibility we get representation theorems for a number of contraction operators of varying strength. In addition it is shown that recovery contraction is a special case that we get if eligibility is explicitly constructed in terms of logical relevance.

In his new paper, “Eligibility and Inscrutability,” J. R. G. Williams presents a surprising new challenge to David Lewis’ theory of interpretation. Although Williams frames this challenge primarily as a response to Lewis’ criticisms of Putnam’s model-theoretic argument, the challenge itself goes to the heart of Lewis’ own account of interpretation. Further, and leaving Lewis’ project aside for a moment, Williams’ argument highlights some important—and some fairly general—points concerning the relationship between model theory and semantic determinacy.

In his new paper, “Eligibility and Inscrutability,” J. R. G. Williams presents a surprising new challenge to David Lewis’ theory of interpretation. Although Williams frames this challenge primarily as a response to Lewis’ criticisms of Putnam’s model-theoretic argument, the challenge itself goes to the heart of Lewis’ own account of interpretation. Further, and leaving Lewis’ project aside for a moment, Williams’ argument highlights some important—and some fairly general—points concerning the relationship between model theory and semantic determinacy.